Humalog (insulin lispro) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Humalog
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Insulin lispro
Class: Insulin analog
Also reported as: Humalog /00030501/

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 71,174 adverse event reports that name Humalog. In these reports the drug is a suspect or interacting product.

In the same period, 40,195 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 2,312 reports in the 12 months to June 2026 and 4,054 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 2,312 (0.2%) name Humalog. Reports from consumers or other non-health professionals were 87.9% of the reports that name Humalog and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Humalog is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 468 reports that name Humalog.
In January to March 2026, FDA received 563.
In April to June 2025, FDA received 1,732.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 1,249 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 71,170 of the 71,174 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 1,249 terms.

Reaction terms in the reports that name Humalog, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 71,174 reports
Blood glucose increasedraised blood sugar reading	28,930	40.6%
Incorrect dose administeredthe wrong dose was given	6,719	9.4%
Blood glucose decreasedlow blood sugar reading	6,374	9%
Drug ineffectivethe medicine did not work as expected	5,120	7.2%
Visual impairmentreduced vision	3,788	5.3%
Underdoseless than the intended dose	2,719	3.8%
Drug dose omissiona dose was missed	2,706	3.8%
Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure	2,217	3.1%
Malaisegeneral feeling of being unwell	2,136	3%
Hypoglycaemialow blood sugar	2,092	2.9%
Blood glucose abnormal	2,025	2.8%
Cataractclouding of the eye lens	1,618	2.3%
Injection site painpain where the injection was given	1,617	2.3%
Haemorrhagebleeding	1,549	2.2%
Falla fall	1,507	2.1%
Visual acuity reducedreduced sharpness of vision	1,382	1.9%
Wrong technique in product usage processthe product was used in the wrong way	1,327	1.9%
Cerebrovascular accidentstroke	1,307	1.8%
Accidental underdose	1,282	1.8%
Feeling abnormalfeeling odd or not right	1,223	1.7%
Memory impairmentmemory problems	1,184	1.7%
Blood glucose fluctuation	1,152	1.6%
Weight decreasedweight loss	1,139	1.6%
Drug dispensing errora dispensing mistake	1,126	1.6%
Wrong drug administeredthe wrong medicine was given	1,083	1.5%
Dizzinesslight-headedness or unsteadiness	1,078	1.5%
Painpain, site not specified	1,046	1.5%
Weight increasedweight gain	1,034	1.5%
Diabetic ketoacidosisa serious complication of diabetes with acid build-up	1,018	1.4%
Nauseafeeling sick	1,009	1.4%
Blindnessloss of sight	991	1.4%
Fatiguetiredness	985	1.4%
Product storage errorthe product was stored wrongly	971	1.4%
Incorrect product storagethe product was stored wrongly	969	1.4%
Product dose omission issuea dose was missed	966	1.4%
Diabetes mellitus inadequate controldiabetes not well controlled	955	1.3%
Headachehead pain	938	1.3%
Loss of consciousnesspassing out	932	1.3%
Myocardial infarctionheart attack	928	1.3%
Hypoacusisreduced hearing	925	1.3%
Neuropathy peripheralnerve damage in hands or feet	869	1.2%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	867	1.2%
Vomitingbeing sick	835	1.2%
Arthritis	826	1.2%
Hypertensionhigh blood pressure	822	1.2%
Hyperglycaemiahigh blood sugar	793	1.1%
Dyspnoeashortness of breath	789	1.1%
Astheniaweakness or lack of energy	769	1.1%
Tremorshaking	767	1.1%
Gait disturbancedifficulty walking	760	1.1%

Download all 1,249 terms of Humalog (CSV)

The counts add to more than 71,174 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Insulin lispro with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Insulin lispro	Generic name	8,209
Admelog	Brand name	958
Humalog (this page)	Brand name	71,174
Humalog Junior Kwikpen	Brand name	751
Humalog Kwikpen	Brand name	3,040
Humalog Mix75/25	Brand name	8,139

Sum of the separately reported names: 92,271. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Humalog, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	824	789	29	51	489	47	8	515	35
2005	636	617	41	19	372	53	4	408	19
2006	619	598	43	19	336	31	4	348	21
2007	655	631	31	15	331	37	11	372	24
2008	736	721	57	16	391	17	1	396	15
2009	821	805	33	26	407	23	2	498	16
2010	892	877	43	36	447	31	5	557	15
2011	877	852	38	29	460	62	7	524	25
2012	691	666	39	26	385	35	5	400	25
2013	273	208	19	10	98	3	4	119	65
2014	2,546	962	52	29	465	33	6	683	1,584
2015	21,257	2,163	60	61	1,013	78	6	1,595	19,094
2016	4,866	1,379	61	64	620	61	9	901	3,487
2017	4,538	1,576	79	46	721	49	18	993	2,962
2018	4,350	1,719	113	42	735	56	6	1,037	2,631
2019	4,516	1,952	97	42	836	109	3	1,181	2,564
2020	4,669	2,030	87	54	937	100	2	1,231	2,639
2021	4,054	1,640	85	48	834	96	0	924	2,414
2022	3,205	1,208	128	39	533	96	3	727	1,997
2023	2,517	868	71	36	396	80	2	543	1,649
2024	2,204	824	55	19	346	69	0	521	1,380
2025	4,337	994	32	27	466	70	4	601	3,343
2026	1,091	435	19	17	182	34	0	294	656

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Humalog, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Humalog, by the year in which FDA received them
Year	Reports
2004	767
2005	630
2006	610
2007	681
2008	658
2009	929
2010	905
2011	886
2012	739
2013	297
2014	2,648
2015	21,340
2016	4,861
2017	4,579
2018	4,359
2019	4,592
2020	4,671
2021	3,965
2022	3,127
2023	2,493
2024	2,135
2025	4,271
2026	1,031

Reports that name Humalog, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Humalog
Age	Reports	Share
Under 2	184	0.3%
2 to 11	876	1.2%
12 to 17	823	1.2%
18 to 44	4,608	6.5%
45 to 64	10,266	14.4%
65 to 74	7,675	10.8%
75 and over	5,681	8%
Age not given	41,061	57.7%

Sex of the patient in the reports that name Humalog
Sex	Reports	Share
Female	39,186	55.1%
Male	29,445	41.4%
Unknown or not given	2,543	3.6%

Type of reporter in the reports that name Humalog
Reporter	Reports	Share
Physician	3,032	4.3%
Pharmacist	1,834	2.6%
Other health professional	2,143	3%
Lawyer	19	under 0.1%
Consumer or non-health professional	62,574	87.9%
Not given	1,572	2.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 89.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Humalog record
Indication as recorded (MedDRA)	Reports	Share
Diabetes mellitus	13,284	18.7%
Type 2 diabetes mellitus	11,090	15.6%
Type 1 diabetes mellitus	7,196	10.1%
Gestational diabetes	402	0.6%
Diabetes mellitus insulin-dependent	241	0.3%
Blood glucose increased	227	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 71,174 reports.

Drugs in the same reports

Other drugs that the reports of Humalog name, in any role, in order of name
Drug	Reports that name the two
Humulin N	3,123
Humulin R	1,679
Insulin glargine	2,894
Lantus	17,737
Levemir	3,731
Metformin	3,797
Novolog	1,879
Toujeo	1,857
Tresiba	1,863
Trulicity	1,505

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Insulin lispro same ingredient
Admelog same ingredient
Humalog Junior Kwikpen same ingredient
Humalog Kwikpen same ingredient
Humalog Mix75/25 same ingredient
Fiasp same class
Apidra SoloStar same class
Apidra same class
Hulio next in the A to Z list
Humalog 25% Lispro 75% Npl next in the A to Z list
Horizant next in the A to Z list
Homeopathics next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for HumalogThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

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Reported Reactions. Humalog: adverse event reports that FDA received. https://reportedreactions.com/drug/humalog/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Humalog as a suspect or interacting product. The 40,195 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Humalog was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Humalog?

No. It is a count of what people reported to FDA: 71,174 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (87.9%), physician (4.3%) and other health professional (3%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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